Jul

2014

Cl II QLAB 10 Core Module

Company:Philips Ultrasound, Inc.
Date of Enforcement Report: 7/30/2014
Class lI:

PRODUCT

QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products. Recall Number Z-2109-2014

REASON
Philips Healthcare has discovered a problem in the Philips Ultrasound QLAB version 10.0 and 10.1 that could result in the erroneous calculation of Ejection Fraction (EF) from the results of a2DQ and aCMQ patient exams.

RECALLING FIRM/MANUFACTURER
Philips Ultrasound, Inc., Bothell WA on 7/9/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
84

DISTRIBUTION
Nationwide

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II QLAB 10 Core Module

Amy Sellers

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